Stability Indicating HPLC Method Development - A Review

Rishikesh S Bachhav; Rushikesh S Mulay

Title:
Stability Indicating HPLC Method Development - A Review

Authors:
Rushikesh S Mulay | Rishikesh S Bachhav

Cite This Article :

Rushikesh S Mulay | Rishikesh S Bachhav "Stability Indicating HPLC Method Development - A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-6, October 2021, pp.250-259, URL: https://www.ijtsrd.com/papers/ijtsrd46342.pdf

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Abstract :
High performance liquid chromatography is most powerful tools in analytical chemistry which assessing drug product stability. It is most accurate method for determining the qualitative and quantitative analysis of drug product. Forced degradation plays an important role in development of stability indicating analytical methodology. Stability indicating HPLC methods are used to separate various drug related impurities that are formed during the synthesis or manufacture of drug product. This article discusses the strategies and issues regarding the development of stability indicating HPLC system for drug substance. Forced degradation studies establish degradation pathways of drug substances and drug products. Forced degradation elucidate the possible degradation pathway of the drug substance or the active pharmaceutical ingredient in the drug product. At every stage of drug development practical recommendations are provided which will help to avoid failure.

Keywords :
HPLC, forced degradation, Stability indicating study

Publication Details:

Unique Identification Number : IJTSRD46342

Published In : Volume-5 | Issue-6, October 2021

Page Number(s) : 250-259

Publisher Name : IJTSRD | www.ijtsrd.com | E-ISSN 2456-6470

Copyright © 2019 by author(s) and International Journal of Trend in Scientific Research and Development Journal. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0) (http://creativecommons.org/licenses/by/4.0)

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